Shao Yong-Fu, Yang Jia-Mei, Chau Gar-Yang, Sirivatanauksorn Yongyut, Zhong Shou-Xian, Erhardtsen Elisabeth, Nivatvongs Supanit, Lee Po-Huang
Department of Abdominal Surgery, Tumor Hospital of Chinese Academy of Medical Sciences, Beijing, China.
Am J Surg. 2006 Feb;191(2):245-9. doi: 10.1016/j.amjsurg.2005.10.019.
Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy. We evaluated the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in cirrhotic patients undergoing partial hepatectomy.
Patients were randomized to rFVIIa 50 or 100 mug/kg or placebo, administered intravenously 10 minutes before surgery and every second hour during surgery. The primary efficacy end points were the proportion of patients receiving red blood cell (RBC) transfusions and the amount of RBCs transfused. The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events.
No statistically significant effect of rFVIIa treatment on efficacy end points was observed. Serious and thromboembolic adverse events occurred at similar incidences in the study groups.
Using blood loss as a transfusion trigger, the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study. No safety concerns were identified.
肝硬化所致凝血功能障碍可能导致肝切除术中出血过多。我们评估了重组凝血因子VIIa（rFVIIa）在接受部分肝切除术的肝硬化患者中的止血效果及安全性。
患者被随机分为接受50或100μg/kg rFVIIa或安慰剂组，于手术前10分钟静脉给药，术中每两小时给药一次。主要疗效终点为接受红细胞（RBC）输血的患者比例及RBC输血量。RBC输血触发阈值为失血500 mL。安全终点包括血栓栓塞及不良事件。
未观察到rFVIIa治疗对疗效终点有统计学显著影响。研究组中严重及血栓栓塞不良事件的发生率相似。
以失血作为输血触发阈值，本研究未证实rFVIIa在减少RBC输血需求方面的疗效。未发现安全性问题。
Zotero 插件